Merit for Life Science Electronic Signatures and Records
Any organization that sells services or products within the US must be in compliance with the 21 CFR Part 11 Electronic Signatures and Electronic Records regulation. This includes systems used by pharmaceutical manufacturers, biotech or medical device organizations in the research, production, and distribution of products such as medical devices, pharmaceuticals, blood, tissue, vaccines, and other biologicals.
The standard electronic signature capabilities in D365 cover many use cases but a couple of key life science requirements are missing.
Merit for Life Science Operations advances Dynamics 365 functionality to support compliance with FDA 21 CFR Part 11 and meet the unique needs of Life Science organizations when it comes to e-signatures and electronic records.
In this video you'll see how Merit for Life Science audit controls helps you:
Ensure compliance with FDA’s 21 CFR Part 11
Capture meaning of signature and sign with unique E-Sig password
Apply a flexible audit logic engine to any table/data set
Gain compete documented control over essential, critical processes
Secure comprehensive audit trails
and more